# FDA 483 - Columbia University Fertility Center - November 28, 2022

Source: https://www.globalkeysolutions.net/records/483/columbia-university-fertility-center/a66c8dc5-3fff-414c-94cd-864dfb7e4fc9

> FDA 483 for Columbia University Fertility Center on November 28, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Columbia University Fertility Center
- Inspection Date: 2022-11-28
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Columbia University Fertility Center in New York revealed significant deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The facility failed to properly determine donor eligibility, maintain confidential donor records, ensure communicable disease testing was performed by certified laboratories, and establish adequate screening procedures. These issues indicate a lack of compliance with regulations governing reproductive human tissue processing.

## Related Documents

- [483 - 2019-07-23](https://www.globalkeysolutions.net/records/483/columbia-university-fertility-center/4e591f2b-44be-4395-99c1-0b5573c0df0b)
- [483 - 2024-12-20](https://www.globalkeysolutions.net/records/483/columbia-university-fertility-center/d3605578-ea0d-4ca5-ad36-5e88bffc2781)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/columbia-university-fertility-center/8defbab7-4935-4788-9494-a7efdbcb3339

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961